MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE QM710; POWER WHEELCHAIR

Model Number QM710

Device Problem Unstable (1667)

Patient Problem Limb Fracture (4518)

Event Date 05/04/2020

Event Type  Injury  

Manufacturer Narrative

Background information: the suspa suspension spring is used to allow the user to navigate variable terrain while maintaining steering and drive control and consists of a cylinder with an internal fluid-pressure system.The suspa spring experiences loss of pressure by failure of one or more internal seals that control pressurized fluid (leak) or through the failure of the spring pin in the locked position.The loss of pressure results in the user experiencing deterioration in stability, raising of the front casters, forward pitching of the chair and/or veering to the side when decelerating which are known issues addressed in the risk management file.If these were to occur the user may be thrown from the chair which could cause injury or impairment requiring immediate, invasive professional medical intervention.The positioning belt is a current control set in place to support the end user's posture and to limit slipping and/or sliding and a performance spring is incorporated as a design control to reduce the severity of occurrence by adding additional pressure to stabilize the front caster arms.Redesign of the suspension spring to allow for higher curb climbing capability was launched in may 2018.Discussion: it is likely that the suspa suspension spring issue led to the user's complaint whereby he fell from the chair.While sunrise has not received confirmation of the severity of the reported broken ankle.A broken ankle is considered a serious injury, due to the malfunction and the fall, it is likely that this malfunction, should it recur, could result in a serious injury.Therefore, this incident meets the requirements for a reportable event.Conclusion: the suspa spring issue is a known issue that has been remediated internally.While the risk ranking is fairly low, it could potentially result in a serious injury and, therefore, is a reportable event.This incident is being reported as a malfunction with serious injury through the fda's medwatch program.Additional information: this complaint has been re-reviewed as a part of a four-year retrospective review and remediation effort based on enhancements made to the company's complaint handling and adverse event reporting processes.A legal consulting firm was consulted for the retrospective review.This mdr is being filed based on the outcome of that retrospective review.

Event Description

Sunrise account manager reported that the end user was coming down his ramp and when he reached the bottom the suspension failed causing the end user to tip forward out of the chair resulting in a broken ankle.

• Brand Name: QUICKIE QM710
• Type of Device: POWER WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93702 1328
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93702 1328
• Manufacturer Contact: devin mcelroy ; 2842 n business park ave; fresno, CA 93702-1328
• MDR Report Key: 12319116
• MDR Text Key: 266420558
• Report Number: 2937137-2021-00036
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00016958052367
• UDI-Public: (01)00016958052367
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: QM710
• Device Catalogue Number: EIPW11
• Date Manufacturer Received: 05/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 95